EN 9110:2015

SLOVENSKI STANDARD
01-april-2015
1DGRPHãþD
SIST EN 9110:2012
Sistemi vodenja kakovosti - Zahteve za organizacije za vzdrževanje letal
Quality Management Systems - Requirements for Aviation Maintenance Organizations
Qualitätsmanagementsysteme - Anforderungen für Luftfahrt-Wartungsfirmen
Systèmes de management de la Qualité - Exigences pour les Organismes d'Entretien de
l'Aéronautique
Ta slovenski standard je istoveten z: EN 9110:2015
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 9110
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2015
ICS 03.120.10; 49.020 Supersedes EN 9110:2010
English Version
Quality Management Systems - Requirements for Aviation
Maintenance Organizations
Systèmes de management de la Qualité - Exigences pour Qualitätsmanagementsysteme - Anforderungen für
les Organismes d'Entretien de l'Aéronautique Luftfahrt-Instandhaltungsbetriebe
This European Standard was approved by CEN on 29 November 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9110:2015 E
worldwide for CEN national Members.

RATIONALE
This standard has been revised to address stakeholder needs through the addition of definitions and
clarification of existing requirements to resolve interpretation issues, and incorporate editorial
corrections.
FOREWORD
To assure customer satisfaction, aviation and defence organizations must produce, maintain, repair
and continually improve, safe, reliable products that meet or exceed customer and applicable
statutory and regulatory requirements. The globalization of the industry and the resulting diversity of
regional and national requirements and expectations have complicated this objective. Organizations
have the challenge of purchasing products from suppliers throughout the world and at all levels of the
supply chain. Suppliers have the challenge of delivering products to multiple customers having
varying quality requirements and expectations.
Industry has established the International Aerospace Quality Group (IAQG), with representatives from
companies in the Americas, Asia/Pacific and Europe, to implement initiatives that make significant
improvements in quality and reductions in cost throughout the value stream. This standard has been
prepared by the IAQG.
This document standardizes quality management system requirements to the greatest extent possible
and can be used at all levels of the supply chain by organizations around the world. Its use should
result in improved quality, schedule, and cost performance by the reduction or elimination of
organization-unique requirements and wider application of good practice. While primarily developed
for the aviation and defence industry organizations providing maintenance services, this standard can
also be used in other industry sectors where a quality management system with additional
requirements over an ISO 9001 system is needed.
Contents Page
RATIONALE . 2
FOREWORD . 2
Foreword . 5
Introduction . 6
0.1 General . 6
0.2 Process approach . 6
Quality management systems — Requirements . 8
1 Scope . 8
1.1 General . 8
1.2 Application . 8
2 Normative references . 9
3 Terms and definitions . 9
4 Quality management system . 11
4.1 General requirements . 11
4.2 Documentation requirements. 12
4.2.1 General . 12
4.2.2 Quality manual . 12
4.2.3 Control of documents . 13
4.2.4 Control of records . 13
5 Management responsibility . 14
5.1 Management commitment . 14
5.2 Customer focus . 14
5.3 Quality policy . 14
5.4 Planning. 14
5.4.1 Quality objectives . 14
5.4.2 Quality management system planning . 15
5.4.3 Safety objectives . 15
5.5 Responsibility, authority and communication . 15
5.5.1 Responsibility and authority . 15
5.5.1.1 Accountable manager . 15
5.5.1.2 Maintenance manager(s) . 15
5.5.2 Management representative . 15
5.5.3 Internal communication . 16
5.6 Management review . 16
5.6.1 General . 16
5.6.2 Review input . 16
5.6.3 Review output . 16
5.7 Safety policy . 16
6 Resource management . 17
6.1 Provision of resources . 17
6.2 Human resources . 17
6.2.1 General . 17
6.2.2 Competence, training and awareness . 17
6.3 Infrastructure . 18
6.4 Work environment . 18
7 Product realization. 18
7.1 Planning of product realization . 18
7.1.1 Project management . 19
7.1.2 Risk management . 19
7.1.3 Configuration management . 19
7.1.4 Control of work transfers . 20
7.2 Customer-related processes . 20
7.2.1 Determination of requirements related to the product . 20
7.2.2 Review of requirements related to the product . 20
7.2.3 Customer communication . 21
7.3 Design and development . 21
7.3.1 Design and development planning . 21
7.3.2 Design and development inputs . 21
7.3.3 Design and development outputs . 22
7.3.4 Design and development review . 22
7.3.5 Design and development verification . 22
7.3.6 Design and development validation . 23
7.3.6.1 Design and development verification and validation testing . 23
7.3.6.2 Design and development verification and validation documentation . 23
7.3.7 Control of design and development changes . 23
7.4 Purchasing . 23
7.4.1 Purchasing process . 23
7.4.2 Purchasing information . 24
7.4.3 Verification of purchased product . 25
7.5 Production and service provision . 25
7.5.1 Control of production and service provision . 25
7.5.1.1 Maintenance process verification . 27
7.5.1.2 Control of maintenance process changes . 27
7.5.1.3 Control of maintenance equipment, tools, and software programs . 27
7.5.1.4 Post-delivery support . 27
7.5.2 Validation of processes for production and service provision . 27
7.5.3 Identification and traceability . 28
7.5.4 Customer property. 28
7.5.5 Preservation of product . 29
7.6 Control of monitoring and measuring equipment . 29
8 Measurement, analysis and improvement . 30
8.1 General . 30
8.2 Monitoring and measurement . 30
8.2.1 Customer satisfaction . 30
8.2.2 Internal audit . 31
8.2.3 Monitoring and measurement of processes . 31
8.2.4 Monitoring and measurement of product . 31
8.3 Control of nonconforming product . 32
8.4 Analysis of data . 33
8.5 Improvement . 34
8.5.1 Continual improvement . 34
8.5.2 Corrective action. 34
8.5.3 Preventive action . 34
9 Notes . 35
Bibliography . 36
Figure
Figure 1 — Model of a process-based quality management system .7
Foreword
This document (EN 9110:2015) has been prepared by the Aerospace and Defence Industries Association of
Europe - Standardization (ASD-STAN).
After enquiries and votes carried out in accordance with the rules of this Association, this Standard has
received the approval of the National Associations and the Official Services of the member countries of ASD,
prior to its presentation to CEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by August 2015, and conflicting national standards shall be withdrawn at
the latest by August 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 9110:2010.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Introduction
0.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design
and implementation of an organization‘s quality management system is influenced by:
a. its organizational environment, changes in that environment, and the risks associated with that
environment,
b. its varying needs,
c. its particular objectives,
d. the products it provides,
e. the processes it employs,
f. its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management
systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to
requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the
associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to
assess the organization's ability to meet customer, statutory, and regulatory requirements applicable to the
product, and the organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration
during the development of this International Standard.
0.2 Process approach
This International Standard promotes the adoption of a process approach when developing, implementing,
and improving the effectiveness of a quality management system, to enhance customer satisfaction by
meeting customer requirements.
For an organization to function effectively, it has to determine and manage numerous linked activities. An activity
or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can
be considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and
interactions of these processes, and their management to produce the desired outcome, can be referred to as
the "process approach".
An advantage of the process approach is the on-going control that it provides over the linkage between the
individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system, such an approach emphasizes the importance of:
a. understanding and meeting requirements,
b. the need to consider processes in terms of added value,
c. obtaining results of process performance and effectiveness, and
d. continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages
presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining
requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to
customer perception as to whether the organization has met the customer requirements. The model shown in
Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed
level.
NOTE In addition, the methodology known as "Plan-Do-Check-Act" (PDCA) can be applied to all processes. PDCA
can be briefly described as follows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer
requirements and the organization's policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the
product and report the results.
Act: take actions to continually improve process performance.

Figure 1 — Model of a process-based quality management system
Quality management systems — Requirements
1 Scope
1.1 General
1)
This standard includes ISO 9001:2008 quality management system requirements and specifies additional
aviation maintenance industry requirements, definitions and notes as shown in bold, italic text.
NOTE 1 Baseline aviation maintenance requirements originate from IAQG developed 9100:2009 standard;
modifications were made, as required, to address maintenance industry specific requirements.
It is emphasized that the requirements specified in this standard are complementary (not alternative)
to contractual and applicable statutory and regulatory requirements. Should there be a conflict
between the requirements of this standard and applicable statutory or regulatory requirements, the
latter shall take precedence.
This International Standard specifies requirements for a quality management system where an organization:
a. needs to demonstrate its ability to consistently provide product that meets customer and applicable
statutory and regulatory requirements, and
b. aims to enhance customer satisfaction through the effective application of the system, including processes
for continual improvement of the system and the assurance of conformity to customer and applicable
statutory and regulatory requirements.
NOTE 2 In this International Standard, the term "product" only applies to:
a. product intended for, or required by, a customer,
b. any intended output resulting from the product realization processes.
NOTE 3 Statutory and regulatory requirements can be expressed as legal requirements.
1.2 Application
All requirements of this International Standard are generic and are intended to be applicable to all
organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an
organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless
these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the
organization's ability, or responsibility, to provide product that meets customer and applicable statutory and
regulatory requirements.
This standard has been developed to benefit maintenance organizations that choose to adopt it,
whether or not holders of a National Aviation Authority (NAA) repair station certificate. This standard
is intended for use by maintenance organizations whose primary business is providing maintenance
services for aviation commercial and military products; and for Original Equipment Manufacturer
(OEM) organizations with maintenance operated autonomously or that are substantially different from
their manufacturing/production operations.

1) With the permission of the International Organization for Standardization (ISO). The complete standard can be
obtained from any ISO member or from the ISO Central Secretariat: 1, Ch. de la Voie-Creuse, Case postale 56,
CH-1211 Geneva 20, SWITZERLAND, or visit www.iso.org. Copyright remains with ISO.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 9000:2005, Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 apply.
Throughout the text of this International Standard, wherever the term "product" occurs, it can also mean "service".
NOTE In the context of this standard, the term "product" is synonymous with the term "maintenance service".
3.1
Airworthy
state of an article conforming to its type design and being in a condition for safe operation
3.2
Article
material, part, component, assembly, appliance, propeller, aircraft engine, airframe, or aircraft which is
listed by the design organization as eligible for installation in product or included in the design data
approved by the authority
3.3
Authority
the aviation authority having jurisdiction over the manufacturer, aircraft owner/operator or maintenance
organization; the authority could be civil or military
3.4
Certified personnel
personnel qualified by an external/internal competent body to carry out special tasks (e.g.,
non-destructive testing certified personnel, licensed maintenance personnel)
3.5
Certifying staff
personnel authorized by the maintenance organization to sign the release certificate for an article after
maintenance
3.6
Counterfeit part
an article produced or altered to imitate or resemble an “approved article” without authority or right to
do so, with the intent to mislead or defraud by passing the imitation as original or genuine
NOTE 1 to entry: Commonly referred to within the industry as a "bogus part".
3.7
Critical items
those items (e.g., functions, parts, software, characteristics, processes) having significant effect on
the product realization and use of the product; including safety, performance, form, fit, function,
producibility, service life, etc.; that require specific actions to ensure they are adequately managed.
Examples of critical items include safety critical items, fracture critical items, mission critical items,
airworthiness limitations items, key characteristics, and maintenance tasks critical for safety.
3.8
Human factors
the study of human behaviour (physically and psychologically) in relation to particular environments,
products, or services and the potential effect on safety. Recognition that personnel performing tasks
are affected by physical fitness, physiological characteristics, personality, stress, fatigue, distraction,
communication, and attitude in order to ensure a safe interface between the personnel and all other
environmental elements such as other personnel, equipment, facilities, organizations, procedures,
and data.
3.9
Key characteristic
an attribute or feature whose variation has a significant effect on product fit, form, function,
performance, or service life, that requires specific actions for the purpose of controlling variation
NOTE 1 to entry: Special requirements and critical items are new terms and, along with key characteristics, are
interrelated. Special requirements are identified when determining and reviewing requirements
related to the product (see 7.2.1 and 7.2.2). Special requirements can require the identification
of critical items. Design output (see 7.3.3) can include identification of critical items that require
specific actions to ensure they are adequately managed. Some critical items will be further
classified as key characteristics because their variation needs to be controlled.
3.10
Maintenance
performance of tasks required to ensure the continuing airworthiness of an article, including any one
or combination of overhaul, inspection, testing, replacement, defect rectification, and the embodiment
of a modification or repair
NOTE 1 to entry: This term applies to the overhaul, repair, inspection, replacement, modification, or defect
rectification of an article that is performed after completion of manufacturing and initial
airworthiness certification by or on behalf of the relevant authority.
3.11
Release certificate
document attesting that a product is released for use (release/return to service) and certifying that the
activities performed, and the results achieved, conform to established organization, regulatory, and
customer requirements with no known nonconformities that would endanger flight safety
3.12
Risk
an undesirable situation or circumstance that has both a likelihood of occurring and a potentially
negative consequence
3.13
Safety policy
top management formally expressed commitment to product safety. This policy should reflect the
organization's philosophy of safety management and outlines the methods and processes that the
organization will use to achieve desired safety outcomes.
3.14
Special requirements
those requirements identified by the customer or determined by the organization, which have high
risks to being achieved, thus requiring their inclusion in the risk management process. Factors used
in the determination of special requirements include product or process complexity, past experience
and product or process maturity. Examples of special requirements include performance
requirements imposed by the customer that are at the limit of the industry’s capability or requirements
determined by the organization to be at the limit of its technical or process capabilities.
3.15
Suspected unapproved part
an article that might not have been or is suspected of not having been produced or maintained in
accordance with approved design data and applicable statutory, regulatory, and customer
requirements
NOTE 1 to entry: This includes: (1) articles shipped to an end user by a supplier who does not have direct
delivery authorization from the approved production organization; (2) new articles that do not
conform to the approved design/data; (3) articles that have not been manufactured or
maintained by an approved source; (4) articles that have been intentionally misrepresented,
including counterfeit parts; and (5) articles with incomplete or inappropriate documentation.
3.16
Technical data
data that is necessary to ensure that the article can be maintained in a condition such that continuing
airworthiness of the aircraft and related operational and emergency equipment is assured. This data
includes maintenance programs, airworthiness directives, service bulletins, repairs/modifications,
operator maintenance manuals, drawings, engineering orders, component maintenance manuals,
technical orders, etc. Technical data shall be acceptable to the authority or approved by the authority,
if applicable.
NOTE 1 to entry: Commonly referred to within the industry as "maintenance data".
4 Quality management system
4.1 General requirements
The organization shall establish, document, implement, and maintain a quality management system and
continually improve its effectiveness in accordance with the requirements of this International Standard.
Maintenance organizations shall obtain and maintain any required quality management system
approvals and any other approvals, certificates, ratings, licenses, and permits required by the
applicable statutory and regulatory requirements. The organization’s quality management system
shall also address customer and applicable statutory and authority quality management system
requirements.
The organization shall:
a. determine the processes needed for the quality management system and their application throughout the
organization (see 1.2),
b. determine the sequence and interaction of these processes,
c. determine criteria and methods needed to ensure that both the operation and control of these processes
are effective,
d. ensure the availability of resources and information necessary to support the operation and monitoring of
these processes,
e. monitor, measure, where applicable, and analyse these processes, and
f. implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this International
Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements, the
organization shall ensure control over such processes. The type and extent of control to be applied to these
outsourced processes shall be defined within the quality management system.
NOTE 1 Processes needed for the quality management system referred to above include processes for management
activities, provision of resources, product realization, measurement, analysis, and improvement.
NOTE 2 An "outsourced process" is a process that the organization needs for its quality management system and
which the organization chooses to have performed by an external party.
NOTE 3 Ensuring control over outsourced processes does not absolve the organization of the responsibility of
conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied
to the outsourced process can be influenced by factors such as:
a. the potential impact of the outsourced process on the organization’s capability to provide product that
conforms to requirements,
b. the degree to which the control for the process is shared,
c. the capability of achieving the necessary control through the application of 7.4.
4.2 Documentation requirements
4.2.1 General
The quality management system documentation shall include:
a. documented statements of a quality policy and quality objectives,
b. a quality manual,
c. documented procedures and records required by this International Standard,
d. documents, including records, determined by the organization to be necessary to ensure the effective
planning, operation, and control of its processes, and
e. documented statements of a safety policy and safety objectives.
The organization shall ensure that personnel have access to, and are aware of, relevant quality
management system documentation and changes.
NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the
procedure is established, documented, implemented, and maintained. A single document may address the
requirements for one or more procedures. A requirement for a documented procedure may be covered by
more than one document.
NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to:
a. the size of organization and type of activities,
b. the complexity of processes and their interactions, and
c. the competence of personnel.
NOTE 3 The documentation can be in any form or type of medium.
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes:
a. the scope of the quality management system, including details of and justification for any exclusions
(see 1.2),
b. the documented procedures established for the quality management system, or reference to them,
c. a description of the interaction between the processes of the quality management system, and
d. a description of the processes and procedures, as applicable, used for:
– establishing and maintaining proficiency of personnel;
– establishing and maintaining rosters for certifying staff/personnel;
– establishing and maintaining the training program;
– establishing and maintaining current approved or accepted technical data;
– performing preliminary inspection of all articles that are maintained;
– the acceptance of incoming articles;
– inspecting all articles that have been involved in an accident for hidden damage before
maintenance is performed;
– conducting the maintenance process in compliance with customer, statutory, and regulatory
requirements;
– performing final inspection and 'return to service' of maintained articles; and
– governing work performed at another location.
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special type of
document and shall be controlled according to the requirements given in 4.2.4.
NOTE Documents include technical data used to carry out maintenance.
A documented procedure shall be established to define the controls needed:
a. to approve documents for adequacy prior to issue,
b. to review and update as necessary and re-approve documents,
c. to ensure that changes and the current revision status of documents are identified,
d. to ensure that relevant versions of applicable documents are available at points of use,
e. to ensure that documents remain legible and readily identifiable,
f. to ensure that documents of external origin determined by the organization to be necessary for the
planning and operation of the quality management system are identified and their distribution controlled,
g. to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they
are retained for any purpose, and
h. to report incomplete or ambiguous technical data to the customer and/or the author.
4.2.4 Control of records
Records established to provide evidence of conformity to requirements and of the effective operation of the
quality management system shall be controlled.
The organization shall establish a documented procedure to define the controls needed for the identification,
storage, protection, retrieval, retention and disposition of records.
The documented procedure shall define the method for controlling records that are created by and/or
retained by suppliers.
Records shall remain legible, readily identifiable and retrievable.
5 Management responsibility
5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the
quality management system and continually improving its effectiveness by:
a. communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements,
b. establishing the quality policy,
c. ensuring that quality objectives are established,
d. conducting management reviews,
e. ensuring the availability of resources,
f. establishing the safety policy, and
g. ensuring that safety objectives are established.
5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of
enhancing customer satisfaction (see 7.2.1 and 8.2.1).
Top management shall ensure that product conformity and on-time delivery performance are
measured and that appropriate action is taken if planned results are not, or will not be, achieved.
5.3 Quality policy
Top management shall ensure that the quality policy:
a. is appropriate to the purpose of the organization,
b. includes a commitment to comply with requirements and continually improve the effectiveness of the
quality management system,
c. provides a framework for establishing and reviewing quality objectives,
d. is communicated and understood within the organization, and
e. is reviewed for continuing suitability.
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for
product [see 7.1, a)], are established at relevant functions and levels within the organization. The quality
objectives shall be measurable and consistent with the quality policy.
5.4.2 Quality management system planning
Top management shall ensure that:
a. the planning of the quality management system is carried out in order to meet the requirements given
in 4.1, as well as the quality objectives, and
b. the integrity of the quality management system is maintained when changes to the quality management
system are planned and implemented.
5.4.3
...